Kevin Parmenter, Power Systems Design Contributor
The Medical Electronics market, typically slow and tested, is undergoing significant, relatively rapid, and recent regulatory changes. These changes will impact designers of medical equipment of all types globally. The medical electronics market has grown very quickly and gone global while emerging economies are seeking high-quality medical care and access to the latest instruments and equipment.
Moreover, the environment for medical equipment is now characterized by more wireless systems in proximity to all medical equipment than ever before. This consists not only of other medical systems with wireless capabilities, also to be considered are patient, visitor and well lets face it the practitioners and medical providers and all humans bringing their wireless gear into the medical care environment.
The concept and implementation of the of MOPP (Methods of Patient Protection) and MOPP (Method of Operator and Patient Protection) is growing and expanding. Isolation barrier specifications at 4KV input to output ratings are becoming more commonplace. All of this has resulted in changes in the defining specification for medical electronics systems, namely EN60601, getting pallet uplift -outlined in the 4th Edition.
This is to keep up with the reality of the operational environment, adding several new aspects to the EMC requirements covering both the emissions of the systems in terms of both radiated emissions, conducted emissions and susceptibility requirements to account for the expansion of wireless devices in proximity of critical medical equipment with the concern of equipment “self jamming”.
As current Chair the PSMA Safety and compliance committee, I invite you to join if you are involved in medical, or industrial power electronics. The latest PSMA newsletter points out that regarding 60601 several key events are occurring and I encourage you to join for updates on this dynamic environment.
Concerning EN60601-1 3rd Ed/A1:2013 – for Europe the mandatory implementation date of 24 December 2018 was pulled in to 31 December 2017. It is still somewhat unclear when the 4th revision overall will be mandatory globally but its recommended to obtain a copy of the 4th revision and prepare accordingly.
The fact is that emerging economies also expect that medical equipment must perform at high altitudes with the same specs as at ground level. As you may know, creepage and clearance requirements needed for medical compliance for safety at ground levels vs. 5000 meters is very, very different. Many emerging economies needing medical equipment expect to be able to meet 60601 requirements for safety and compliance with margin anywhere on earth where there are patients – Mexico city, Columbia, parts of China in a pressurized cabin of an aircraft (rotary or fixed wing), or what have you.
This will require the power supply provider to have done their homework for medical power supply design, which can meet these requirements at 5000-meter elevations. Please feel free to join the PSMA Safety and compliance committee to learn more about these changing requirements for medical equipment safety and compliance issues as they unfold.